8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVI MICRO 285CM INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·February 28, 2013
SPACEMAKER PREPERITONEAL DIST BALLOON
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·January 20, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 6, 2014
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013